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1. Do not cross use SpO and CO sensors between epidemical and unepidemical patients before sterilization Do not connect the monitor sensor AC adapter and base to any other equipment CAUTIONS All equipment connected to the monitor must comply with IEC 60601 1 Use only recommended SpO and CO sensors and cables Other sensors or cables may cause improper monitor performance NOTES Changes or modifications not approved by the manufacturer could void the user s rights to operate the equipment Ambient light movement electromagnetic interference artifacts dysfunctional hemoglobin and intravascular dyes etc may cause inaccurate SpO2 measurements Do not sterilize any sensor by irradiation steam or ethylene oxide Do not immerse cables or sensors completely in liquid or cleaning solutions 1 2 Product Label Vital Signs Monitor Model NT1D NTXXXX XXXXXX ual 7 N 2 4 IN Bn UE zoo qe Battery GP 240AAHC 12 4 G W il NEWTECH ING 6th Industrial Road NO 1 Chuangye Dasha Building C Nanshan District Shenzhen Guangdong 518087 P R China Shanghai Intemational HoldinaCorp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany Tel 0048 40 2513175 Fax 0049 40 255726 L Rx Only FCC ID XPANT1D C Eo Figurel 1 Product label 1 3 Introduction 2 Introduction 2 1 Product Introduction NTID is a handheld vital signs monitor that continuously
2. CO Warm Up and CO need compensation 4 Press MENU again to select Set CO2 Press OK to change CO waveform speed and CO configuration parameters according to operating environment i e air pressure temperature 5 Use Up Down Right or Left buttons to move the cursor When the cursor is on OK or Cancel press OK to save or cancel and exit Pressing MENU button will also exit the screen 6 Calibration The unit will perform auto calibration with the data put in When the operating environment changes the current carbon dioxide value needs to be entered through the following 1 Input the barometric pressure to the Press field the unit is kPa 2 Input the room temperature to the Temp field the unit is C 3 O2 Compensation Range 0 to 100 Resolution 1 Default 16 4 Balance Gas is Air barometric pressure O compensation Uit current CO units 6 An anesthetic agent 5 5 4 Set Patient Information In the setting menu you can choose Patient Info menu to set patient ID gender and type as shown in Figure 5 10 5 7 Displays and Functions Figure 5 10 Set Patient Information Operations 1 Use Up Down Right or Left buttons to move the cursor When the cursor is on OK or Cancel button press OK to save or cancel and exit Pressing MENU will also let you exit the screen 2 You can set up patient ID from 0 to 99 patient gender and patient types Adult or Ped
3. Service Contact Shenzhen Newtech Inc 6th Industrial Road NO IChuangye Dasha Buildings C Nanshan District Shenzhen Guangdong 518067 P R China 3 F Zhongjian Industrial Building 1 302 18 Shekou Yanshan Road Nanshan District Shenzhen Guangdong 518067 P R China Service Information Tel 86 755 26546717 86 755 26525910 86 755 26546704 Fax 86 755 26525912 E mail sales sznewtech com Http www sznewtech com Authorized EU Representative Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany Tel 49 40 2513175 Fax 49 40 255726 Product information Product model NTID Product name Vital Signs Monitor Version information This version is subject to change or upgrade without notice Version 1 7 Issue date 2012 5 File Number NTI D CE 091B Preface Preface This operating manual introduces the monitor s performance operation methods and safety information This manual is intended for professional healthcare personnel and those who have experience in operating monitoring equipment NTID Series Vital Signs Monitor provides SpO monitoring Pulse rate PR monitoring End tidal carbon dioxide EtCO monitoring Respiration rate RR monitoring CO and SpO waveform display Audible and visual physiological and technical alarms Trend graph and trend table review Alarm event records review e History data storage Rechargeable
4. option as shown in Figure 5 8 Figure 5 8 Set SpO Not valid for CO only module Operations 1 Use Up Down Right or Left buttons to move the cursor When the cursor is on OK or Cancel button press OK to save or cancel and exit Alternatively you may press MENU to exit 2 Move the cursor to Pleth Speed Averaging Time or Pleth Visual Alert press OK button first and then use Up Down buttons to change the values Press OK to confirm your setting No Name Option Pleth Speed High Low 4 8 16 This is the dynamic window of time 2 Averaging Time used to collect the values that are averaged to provide the value displayed on the screen Is 10s 30s This setting determines how Pleth Visual Alert quickly the color of the waveform changes during an alarm condition to provide a visual alert Red for high priority alarm and yellow for middle priority alarm 5 6 Displays and Functions 5 5 3 Setting CO In the setting menu you can choose Set CO option which is the same for both mainstream and sidestream CO Operations 1 Connect CO sensor to the monitor first See Chapter 3 for details 2 Press MENU and select Set CO2 Press OK to see the following p EE Figure 5 9 Set CO Not valid for SpO only module Note The parameters shown in this screen are factory default values 3 Press OK to activate CO The main screen will show message saying CO Opening
5. DO NOT insert any object such as a brush into the CO airway adapter Irreparable damage may occur to the CO windows C Maintenance Schedule CO Sensor should be compared against calibration gas every 12 months NOTE Accuracy is affected by temperature and barometric pressure D CO Accuracy Check The following procedures are recommended to be performed as part of a periodic maintenance schedule to check CO accuracy of the sensor 1 Zeroing Refer to chapter 7 4 CO Sensor Adapter Zeroing 2 Calibration Open the MENU and select Set CO Set up values of all parameters pressure temperature unit oxygen compensation etc according to the actual environment Press OK key to confirm your calibration NOTES Do not autoclave ethylene oxide sterilize or immerse the monitor and its accessories in liquid Turn off the monitor before cleaning Do not immerse SpO and CO sensors in liquid N WARNINGS If there is any internal part of the SpO and CO sensor exposed please contact qualified service personnel for disposal 10 4 Troubleshooting and Maintenance 10 6 Periodic Safety Checks The following safety checks should be performed every 24 months by qualified personnel who have adequate training knowledge and practical experience to perform these tests Inspect the equipment for mechanical and functional performance e g speaker indicator light button response 9 Inspect the sa
6. Inc It should not be copied reproduced disseminated or distributed without prior written permission from Shenzhen Newtech Inc Copyright reserved by Shenzhen Newtech Inc Statement Newtech Inc reserves all rights for the final interpretation of this user manual Newtech Inc is responsible for product safety reliability and performance when all below conditions are met Product installation update improvement and repair are all performed by authorized personnel of Newtech Inc e Related electronic devices are in compliance with national standards This user manual has been followed when operating the device Guarantee Free Service All products within warranty period enjoy free service Service Fee Newtech charges service fees for any product that is out of warranty Newtech charges service fees for below service even though the product is within warranty period man made damages improper operation voltage over limit natural calamities replacement of components and repairs without Newtech permission Return To return a defective product to Newtech a Return Material Authorization RMA number from our service group 1s required This RMA number together with product model and serial number s should appear on outer transportation carton Any return with the serial number not recognizable will not be accepted The customer should bear the freight including customs declaration fee for repair
7. Welcome to the Found New Hardware Wizard Choose Install from a list or specific location Note If there is no automatic window you may double left click the icon on the bottom right corner of the desktop Welcome to the Found New Hardware Wizard lin maze betty posa Fala orn bee Hh Lege 118 E F dE pia aidea comer ith aem ird aliaiion CD E im Hhxepee deh miii d ee uif dio ou narii Prats eared ini do 771 ril nhu rom dnt im PO ilie Fn cami e Prog al Arcem ii ot p pescar Tate lafsaacedi Has dwaru Updalu Wacard Meare chepe pour paweh aed inataBahon ophions Ce feach for fe best dteu m there kaima Ues the check bams beks bo lind ox expand the dink peach shich nekadar local pates gj removeable media Tres best drem founet wd be niae Search removable inea oper CD FIOR Ie Ires lens keson in the search FA Euer Pii Express Ud Graves Bee C Don seh 1 wll rhecre Hh cde to inii Chior thet eor Vs trie the ideae deer Fini adie Velraenes chats ril gun Theat a crema you chen vell hes thee bau maich For pour haedeascs sea J Wes tees 4 Click Browse and choose the path G Driver F32x Express USB Driver Click Next and start installation Hardwarn Update Wizard Pleme wae hike lho eeceed recher pa UygLib Iya To i Cs ee ra a mamamnuamamsamuacuamrmam Data Output 5 After installation is completed you will see the window Completing the Found New Ha
8. 59 SENE SPO causada audae quitte aie onu ed 5 6 DW Q0 NEQNE NRI EE E AEA E DURER DEREN DEN 5 7 5 osset Patient Mito ni atom istics we oto dre din dee odere MN RUNI pep CRI ERES dept 5 7 5 5 AdS ENO IIIA oie poches T ient ree oen does Pu ber ed ea ERES 5 8 5 5 6 Sette Date and Title ce cca op E ENDE 5 0 IEPENE LanoudSe osdantesedm whee eins ohare qitod itm tbe atius t 5 3 5 5 95 eU P RCI oet eni oed eiii hadi ude ci Eoeledbt ad abate Abend etos Db cod 5 0 25 539 Data OUEDUE caepit I iecoris a A A bs eL Pob Reece 5 10 5 5 TO Module ODOM attt Qut a eina cun 5 10 DD AC ME CUNO NND NE 5 10 5 52 2 S VSte Hm Morna HOT ad desactivado 5 10 5 6 Audible and Visual Indications eene 5 11 VI OMILOLING SP OF 1 titel ust eai Cote etui Ce eii Cot die dedi otis redi ot die edi aai 6 1 Oh CISHEEO A E tud E duabucuia tit bam ad PEU DUE rb C EMEN dUEE 6 1 6 2 Theory 0f Measure fe Es oie dan iden cock ond ac aN E E E pa obses 6 1 6 3 Abnormal Conditions of SpO Measurement sse 6 2 6 4 Applying SDOS SODSOE cies dedo a siue ts E deeds 6 2 6 5 Measurement Restrictions auos re eia te ete te aet aora aee eut nr een p R 6 3 IVEOMITOTINS Oo cR 7 1 vo beneral DescriDEOB usse UE EU E M UII T DM UL IdeU 7 1 T2 Theory Ol NICASUTEIMCI ig e tenu niece natia n eR ON UE 7 1 7 3 Applying the C O5 SENSO eos irr Eon eR Orten ER UE x eR OC ERU n ROC EGAT 7 1 TACO Sensor Adaptet Zeron emer eene umet oe oreet tee Pe roten ees 7 2
9. Do not dispose the battery pack in fire or it may explode Be sure to follow local regulations and recycling instructions regarding disposal or recycling of batteries N WARNINGS The monitor is not suitable for use in the presence of flammable anesthetic mixtures with air oxygen or nitrous oxide DO NOT recharge alkaline batteries To ensure patient electrical 1solation connect only to authorized AC adapters that provide patient electrical isolation Do not use unauthorized AC adapters To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient f any batteries have any leakage stop using these batteries and follow local regulations and recycling instructions for disposal or recycling of batteries 3 2 Unpacking and Installing Carefully route cables to reduce the possibility of patient entanglement or strangulation To ensure accurate performance and prevent device failure do not expose the monitor to extreme moisture such as rain DO NOT mix use Ni MH batteries and alkaline batteries When changing batteries replace all batteries with fresh ones Use accompanying batteries only NOTES Check the batteries periodically for corrosion Replace batteries if corrosion is present otherwise it may cause damages to the monitor 9 Insert the terminal of each battery first Compress the battery terminal spring until the
10. Press the On button again to enter normal operating mode 5 If the monitor is working the battery icon will flash NO JU N WARNINGS Do not plug the monitor into the base in the wrong direction Make sure that Ni MH batteries are in use while charging DO NOT charge alkaline batteries or any other type of batteries DO NOT mix use different batteries When there are no batteries in the monitor and use the base as external power it is possible to lose data Make sure to turn off the monitor before disconnecting from the base 3 5 Installing Wireless USB Adapter This equipment has been tested and found to comply with the limits for a class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment may generate radiation If not installed and used in accordance with the instructions It may cause harmful interference However there is no guarantee that interference will occur in a particular situation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures 1 Reorient or relocate the main device 2 Increase the distance between the equipment and receiver 3 Consult the dealer or an experienced tech
11. Sensor and Adapter A Cleaning and Disinfecting CO Sensor Use a cloth dampened with isopropyl 70 alcohol 10 aqueous solution of sodium hypochlorite bleach disinfectant spray cleaner such as Steris Coverage Spray HB ammonia or mild soap Wipe down with a clean water dampened cloth to rinse and dry before use Make certain that the sensor connector is cleaned and dried before reuse 10 3 Troubleshooting and Maintenance B Cleaning Adapter Reusable adapters Before reusing the adapter ensure the windows are dry and residue free and that the adapter has not been damaged during handling or the cleaning disinfecting procedures Clean by rinsing in a warm soapy solution followed by soaking in a liquid disinfectant such as 70 isopropyl alcohol a 10 aqueous solution of sodium hypochlorite bleach a 2 4 luteraldehyde solution such as Cidex Steris System 1 or ammonia It should be rinsed out with sterile water and dried Can be disinfected by means listed below 1 Steam Autoclave adult adapter only 2 Immerse and soak in Cidex or equivalent 2 4 glutaraldehyde solution for 10 hour soak 3 Immerse and soak in Perasafe or equivalent 26 peracetic acid solution for a 10 minute soak 4 Cidex OPA follow the manufacturer instructions for use Disposable adapter Treat all single patient use airway adapters in accordance with institutional protocol for single patient use items
12. also affect monitoring A blood pressure cuff is inflated on the same extremity as the one with the sensor attached Replace sensors if necessary Remove disturbing equipment 4 No pulse shown on the indicator bar Check sensor connections with the patient cable as well as the monitor Replace the sensor Try a new sensor or contact your local service group for help 10 1 Troubleshooting and Maintenance 5 PR SpO EtCO RR or Pulse rate is erratic intermittent or incorrect May caused by EMI Reposition the SpO and CO sensor Patient must remain still to obtain an accurate measurement Power off nearby equipment and then power up again to locate the interfering equipment Change the orientation and position of the interfering equipment Keep the interfering equipment far away from this monitor 6 Sudden shutdown of the monitor Replace or recharge batteries Check power cable connection e If the above remedies are not effective contact authorized service representative 7 Instrument halts or has no response for the monitor Remove the batteries Reinstall the batteries and start it manually Ifthe above remedies are not effective contact authorized service representative 10 2 Technical Assistance If you need technical information and support or to order accessories and operating manuals please contact your local representative and specify the so
13. dee dee Low Voltage blink Dee dee dee dee dee Every 10s The red light blinks in high priority Dee dee dee The yellow light blinks in medium Every 10s for high priority The related parameter values priority Every 25s for will blink at the same time medium priority i The red light will blink and the icon E Dee dee dee dee dee 5 No Pulse will be displayed Dee dee dee dee dee Every 10s Monitoring SpO 6 Monitoring SpO 6 1 General SpO measures functional blood oxygen saturation It measures the percentage of oxyhemoglobin It does not measure carboxyhemoglobin or methemoglobin For example if 97 of red blood cells in the artery are oxygenated then blood has 97 blood oxygen saturation The monitoring SpO value reading would be 97 SpO measurement is a non invasive continuous measurement through a SpO sensor attached to a patient finger The sensor is connected directly to SpO module There are three types of display for SpO percentage 76 pulse rate and SpO waveform 6 2 Theory of Measurement Pulse oximetry is based on two principles 1l The oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light the range of red wavelength is 660nm 666nm and the range of infrared wavelength is 880 940nm i e Spectrophotometry and 2 The volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse i e plethysmography A
14. down the monitor normally or when in low voltage Do not take batteries out abruptly when the monitor is working or in the process of shutting down to avoid data loss 2 When using external an AC adapter or a charging base for power supply if there are four Ni MH batteries you can take batteries out when the monitor is working or in the process of shutting down If there are no batteries you can only unplug the adapter or take the base away only after the monitor is shut down normally You can not unplug the adapter or take the base away when it is working to avoid data loss Using SpO sensor incorrectly may do harm to patient s skin Check whether the SpO2 sensor is applied correctly according to the sensors instructions for use Loss of pulse signal can occur if a blood pressure cuff is inflated on the same extremity as the one to which a SpO sensor is attached DO NOT alter or modify SpO and CO sensor Alterations or modifications may affect performance or accuracy Using the SpO sensor in the presence of excessive illumination may result in inaccurate measurements In such cases cover the sensor site with an opaque material DO NOT use SpO and CO sensor if the sensor or the sensor cable appears damaged DO NOT lift the monitor by SpO sensor or CO sensor cable as they could disconnect from the monitor causing the monitor to fall on the patient To ensure patient safety do not place the monit
15. graph screen h3 U om cm 6 b SpO Only c CO Only Figure 5 3 Trend Graph Screen Displays and Functions EtCO trend Draws EtCO trend in a time span according to graph EtCO2 history data for analysis Marks the range of RR trend graph alarm limits RR trend graph Draws RR trend in a time span according to RR history data for analysis 9 Timespan Marks the time span according to setup Page Up Down Selects the page of trend required Marks on the trend graph Maximum 2 marks In the trend graph screen press OK key to enter operation mode Press Right Left buttons to move the cursor Press MENU to exit Page Up Down Move the cursor on it and press OK Press Right Left buttons to select the desired page Press OK key to exit Marker Button Move the cursor on it and press OK to place a mark of current time on trend graph The mark will move leftward at the trend graph with time NOTES The real time trend data will be cleared when you start up the monitor or change patient ID every time Graphs are protracted step by step from the right side of the screen to the left until it fills the screen and then the waveform will move leftward If there is no monitored patient the trend graph still moves leftward The time span of the current trend is different according to different interval setup The maximum span can bel8 hours The history trends will be covered by a new trend if the monit
16. monitors end tidal carbon dioxide EtCO respiratory rate RR oxygen saturation SpO and pulse rate The unit is intended for monitoring only and must be used in the continuous presence of a qualified healthcare provider The unit transfers history data to PC through a USB adapter It is for use in any environment where continuous noninvasive monitoring of these parameters is desired including hospital and hospital type facilities The monitor is intended for use on adult and pediatric patients The product is composed of monitor SpO sensor Mainstream Sidestream CO sensor charging base wireless USB Adapter and PC software The product has input and output ports Input SpO sensor port CO sensor port Output Transfer data to USB adapter wirelessly NOTE Using the monitor with excessive movement may cause inaccurate saturation measurements 2 2 Features SpO monitoring Pulse rate PR monitoring EtCO monitoring Respiration rate RR monitoring CO and SpO waveforms display Audible and visual physiological and technical alarms Trend graph ad trend table review Alarm event records review e History data storage English language interface Internal batteries External power supply and charger Wireless history data transmission wireless USB adapter and PC software 2 3 Basic Theory of Operation SpO theory of operation Pulse oximetry is based on two pr
17. of mechanical ventilator 7 4 CO Sensor Adapter Zeroing The sensor is compatible only with appointed CO airway adapters Each airway adapter has its own optical characteristics The adapter zeroing allows the CAPNOSTAT to adjust to the optical characteristics of each different adapter types Zeroing request may occur for the first time when a particular CO Sensor is connected to a particular Host or pluged in off or if a change is detected by CO Sensor Procedures of Adapter Zeroing 1 Connect the CO Sensor to the Monitor 2 Turn on the monitor If it is the first time you switch on CO place the CO adapter into a clean and dry CO sensor that is exposed to air and away from the sources of CO including ventilator patient and your own breath Do not operate within 20 seconds 3 Press MENU and select Set CO option Set On for CO Switch 4 Choose Clear and CO2 information column will display CO Zeroing and CO Zero OK In the process of zeroing do not make any operation e g breathing or key pressing Otherwise the zeroing operation will fail The time for zeroing is 15 20 seconds CO information note field will disappear after Completing Zeroing setup CO shows operational status it means zeroing process is completed Press MENU key turn back to main window Main window CO waveform will change to thick lines when occur following 1 Check CO adaptor 2 CO need c
18. on if the monitor is turned on It will conduct self test during startup and display below contents 1 Software version 2 Self test in progress showing status check of the disk power indicator and speaker below the software version number 3 If you hear dee sound and the power light is on the self test is completed successfully If not do not continue to use this monitor contact your representative or manufacturer There is a pop up screen to set up system time manually if there is no time set up in the system or the time is lost See Figure 4 6 Figure 4 6 Setting System Time N WARNINGS Make sure that you can hear dee sound and the power light is on If not do not use this monitor Do not lift the monitor by the sensor cable because the cable could disconnect from the monitor causing the monitor to drop on the patient Make sure that the speaker is not blocked or covered Otherwise you may not hear alarm sound 4 3 3 SpO and CO Monitoring SpO measuring is initiated automatically after turning on the monitor Follow below procedures to start monitoring 1 Apply SpO sensor correctly and place patient s finger in position 2 The monitor will search pulse for 10 seconds 3 If pulse search is successful values of SpO and PR will display in SpO and PR areas Pulse indicator will change together with the pulse Speaker will generate dee dee sound with the pulse Termino
19. pulse oximeter determines SpO by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LEDs in the oximetry probe serve as light sources a photodiode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial bemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its SpO measurements on the difference between maximum and minimum absorption i e Measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood The Pulse oximeter determines SpO and pulse rate by passing two wavelengths of light one red and one infrared through body tissue to a photodetector During measurement the signal strength resulting from each light source depends on the color and thickness of the body tissue the probe placement the intensity of the light sources and the absorption of the arterial and venous blood including the time varying e
20. 0601 1 2006 Medical electrical equipment Partl General requirements for basic safety and essential performance DEDE ENG0601 2 49 2006 Particular requirements for the safety of multifunction Patient monitoring equipment EMC conformity EN60601 1 2 2007 Medical equipment Partl 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Usability Medical electrical equipment Part 1 6 general requirement EN 60601 1 6 2007 requirements for basic safety and essential performance collateral standard usability Software requirement EN62304 2007 Medical device software Software lift cycle Processes Medical electrical equipment Part 1 8 General requirements for safety Collateral Standard General Alarm conformity IEC60601 1 8 2007 requirements tests and guidance for alarm systems in medical electrical equipment and medical systems in medical electrical equipment and medical electrical electrical equipment Particular SpO Particular EN ISO9919 2009 requirements for the basic safety and essential standard performance of pulse oximeter equipment for medical use EN ISO Medical electrical equipment Particular CO Particular 21647 2004 requirements for the basic safety and essential standard performance of respiratory gas monitors A 4 Appendix A ISO 10993 1 2009 Biological evaluation of medical devices Biological compatible TII pato and testing ISO 10993 1 requiremen
21. CC NTID Vital Signs Monitor Operating Manual TO NEWTECH Table of Contents Table of Contents I M T T 1 1 Ll Sale by InfOrimall oDe a a T deed l 1 Zi Product Eabel uu eb ete b dt eb eut eich Shes hut mates talus 1 3 De MEO IC 10 Tesh PE T E dios sans eau OS sense cau O E sans cscs aa E R OE E T 2 1 2al Product UE OC UC CIO Toe ie ose ette rcatoceamedad ican red baee teas red see tess red eee e 2 2 23Peal tes oie Reed esis ristias eben id ese eee 2 2 2 Basic Theory of Operation iecit ode te te mt i 2 2 Mee Ulan E Oy NE E ONENI fast ei etui fa tel Mature dette ustedes 2 2 S Unpacking and Installitte i eee iie ete eoe oer e iere eee E eee ebore eee een Ere eben rere T 3 1 SM aj or Kel dite T 3 3 2 T stalline Battetlgsiudioasdseete dep ettet he a dta c e adhere ence tune 3 3 3 Installing Power Adapt esas d etur qutbus Ree bur pe toco Ute ads pa tue eee uet tue Ral 3 3 3 4 Tnstallme Base ete ea ede etie ius 3 4 3 5 Installine Wireless USBAdapte au dii EO ERO edo EIU 3 4 3 60 5ensor PIaCemetll ua tube tiat utt atas tas ieoisau f desayuno dues 3 5 OCU MAO T RR T E E ET EE E E EE E S EE E S EES E NE 4 1 KEMAN SEEQC DUTO inie E tet bote te n reti 4 7 2 General DeserrpHIOE es d oes ce pt Rs euh e s uas eu pO tu E ee E 4 4 3 Basic Operation cu etus ura uice Ua t ie sented Ubi epis Docs ped Cds 4 2 2 9 JL DUCCOLDS itae oae Rap ciis ion Rao Gee pueda p Utd Rub ONIS tuU D eM OU atu 4 3 2d 2 POWERS Lo 0 Se NC Oa eres redes O
22. CR eot ies 4 3 43 35 59 pO5 and CO MOI Orne 3 tance eoe e e Lb p imt bb eee s 4 4 4 3 4 Informatott Dat oreroraa a A a osea ate maps dechs 4 5 d 35 Itu s DAE os tadbefasc sine budufos Mitto E dia tede mes du acu a aed 4 5 23 0 PULSE Tote Vo LUfHleuocidistaons dieta idi aids es dias Ent ON E Ent UN eds es 4 5 4 3 7 Battery Capacity Indicator and Recharge ssuuuusee 4 6 A SS POW CHING OLD secs xistseaz ae etatupuse tutae a autas ao tdt edad a aaa tes eee 4 7 A ANE WICC Stord o Eatona tue Reate E Rebate incen a oque tue EEEa 4 8 45 Environmental PPOLCCLIOT aesir bod uote ueniat lot cami eee eaa teet 4 8 4 6 Pertormance related Factors ssh HOD HD 4 8 5 DIS Plays and BUDCHOHS 552200290650 01 019i etes opi ete oo eee eai o Ee ooo eee eei otro oe deer eo do 5 1 5S JT Main Wim LOE Sh CC ip snieni de NOI Rebeca edu duca dabunt bium tee 5 V2 BIOL Barn SG EG DG toad oie enr bean dated hae eta deere race eee ade 5 Table of Contents Jo Reaktime Trend SOreeliau esce dubeducsiuo suec idube ibo afa usus edle uetus Ref 5 2 5 3 Al Trend Graph Scree ionem odio aedem fecha 5 2 5 52 Trend Table SC EGET Ao uen Dr ae e o eu er ens EE Eus 5 3 523 3 History Trend ou edet m dies a a ER REIN SER SRI eR UD 5 4 S d Event Fable SCEeSITa usur tu otio aes pUup E NU Rub DRM REO np bu do Qu Gol uen deba 5 4 DO IVF ay ONS oa cas tetas a d e casei Len uti tara Leti tas toad La I as ense Lets d 5 4 5 5 T Sep ACIER S o iE E utes 5 5 5
23. Left buttons to move the cursor Press OK to change values Press OK again to exit 2 When the cursor is on OK or Cancel button press OK to save or cancel and exit 5 5 7 Setting Trend Select the Set Trend submenu in the setting menu and you can adjust the trend record steps as shown in Figure 5 13 N WARNINGS If you change the steps the saved data will be lost Figure 5 13 Set Trend Operations 1 Use Up Down Right or Left buttons to move the cursor When the cursor is on OK or Cancel press OK to save or cancel and exit Pressing MENU can also exit 2 Move the cursor to step press the Up Down key to change the step value The default value is 10 seconds Runtime Trend Step 1s 5s 10s 30s 60s It means the trend data saving intervals in the monitor History Trend Step 1s 5s 10s 30s 60s It means the trend data saving intervals you can watch on a PC 5 9 l 2 Displays and Functions Note Any adjustment of trend intervals or date time will cause the current run time trend date being collected to be erased 5 5 8 Data Output In the setting menu choose Data Output option to enter data output screen as shown in Figure 5 14 Waiting for PC Figure 5 14 Data Output Operations 1 Select Data Output in the setting menu 2 Plug wireless USB Adapter into USB port on PC Run the history data analysis software Choose Connect to Device on PC 3 If the device is f
24. Mainstream or Sidestream CO sensor 3 For starting CO monitoring refer to chapter 5 for more information Note Do not remove the sensor by pulling the cable 3 6 Powering Up 4 Powering Up 4 1 Main Structure The monitor is composed of main unit SpO Sensor CO Sensor and the base 4 2 General Description Figures 4 1 to 4 4 are the pictures of the monitor front panel display screen charging base and rear top views of the monitor Figure 4 1 Front Panel Number Description o SpO Socket Connects to SpO Sensor 2 CO Socket Connects to CO Sensor 3 Power Indicator Indicates the monitor is power on s Buon Operation buttons 6 Front Cover Protects the internal components Figure 4 2 Base View 4 1 Powering Up Figure 4 3 Rear top View l D 3 8 Sp0 Sensor Socket Connects SpO Sensor EE 02 o3 EES e i 4 3 Basic Operation N WARNINGS The monitor is a prescription device and is to be operated by qualified personnel only Do not lift the monitor by the cable because it might disconnect from the monitor causing the monitor to drop on the patient 0 Prior to using the monitor carefully read the manual and accessory directions for use all highlighted precaution information and all specifications NOTES The monitor is intended to use only as an adjunct in patient assessment It must be used in conjunction with clinical signs an
25. ND ATAU OULU sae RE RP Cc E aaa 8 1 8 1 Driver Installation and Copy of Data Analysis Software 8 S LHrUSB Driver Installation 22er anu A ES 8 1 8 1 2 Copy the Folder History Data Viewer 8 1 11 Table of Contents 8 2 Data Transmission and Deletion sse 8 2 9 Conrpurdttot dnd ACCESSOFIES cedere et ere cobarde resa tere eo bored tese esso bored u tesa eue so eode 9 1 9 1 Maximum Configuration of NTID eessen aran N 9 9 2 Optional Accessories for NTID uu ccccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeess 9 10 Troubleshooting and Maintenance 9 20 ev eo Coo ero s eoe ro Dee e recorre tope eurer ene soo 10 1 IO I LOPS ANG SODULOBS eoe te rena ibo Oen Pa o ooo inte oe te retten 10 1 102 Technical ASS1s ane eie ini dietus iren a abose 10 2 10 3 Eactory Default Values uiae tu o nete at e anetaetuam ate antes ate antes 10 2 TO d DEO UC RE MITE eR ee ee ed du tudo 10 2 10 5 Maintenance and Cleaning etie i R A En o Enea 10 2 10 6 Periodic Salety Check S sme be tu Poe Poe bet is teste e alts 10 4 10 TOUA IMEE aiea Dustin uates Ue ect tappa epe etaed O 10 5 Appendix XS SDeCIICall gll Soscusdeees esie stisa veda saaducsasvsueciasvacd Esei en se Eee vus EE A 1 Appendix B EMC Electro Magnetic Compatibility eeeee B 1 iii Service Information Service Information Intellectual Property Information contained in this manual is the property of Shenzhen Newtech
26. at the sensor is properly applied and cover the sensor site with Opaque material If patient movement presents a problem try one or more of the following remedies Ensure that the sensor is properly and securely applied Move the sensor to another site Use an adhesive sensor that tolerates some patient motion Use a new sensor with fresh adhesive backing Try to keep patient quiet 6 4 Monitoring SpO NOTES e Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements You can select sensor types to determine how to deal with patient and environment Do not sterilize by irradiation steam or ethylene oxide Wipe the monitor with cloth dampened with soft suds and wipe the surface dry Wipe the sensor with cloth with alcohol if necessary Note Do not spray or pour any liquid directly onto the monitor accessories or consumables N WARNINGS Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and patient conditions Tissue damage can be caused by incorrect application or inappropriate continuous measurement of SpO gt Inspect the sensor site as directed in the sensor Directions for Use 9 Inspect the monitoring site every 4 hours for skin integrity 6 5 Monitoring CO 7 Monitoring CO 7 1 General Description The CO Sensor is used for con
27. atient ID right click and select Transmit data or Delete data to send data of this ID to PC or delete the stored trend data of the ID in monitor as shown below a u F md md omn tns a Oe e lb kmda e 8 3 Configuration and Accessories 9 Configuration and Accessories 9 1 Maximum Configuration of NTID NTID D400AL 160108 SpO Sensor LoFlo Or Sidestream CO Sensor B NHbPHI Giang Base T 5 O MamemmeCad Note This maximum configuration is just suitable for the SpO and CO Module not for SpO only module or CO only Module 9 2 Optional Accessories for NTID Digital One Patient Use SpO2 Sensor Adult D400A 160108 Digital One Patient Use SpO2 Sensor Adult Large D400AL 160108 Digital One Patient Use SpO2 Sensor Pediatric D400P 160108 Digital Y type SpO2 Sensor Neonatal Y400N 160108 e Olaris Digital Finger SpO Sensor Adult S400A 160108 O 0 1 0 0 0 0 0 9O0o WP400PI 160108 Solaris 9 Troubleshooting and Maintenance 10 Troubleshooting and Maintenance N WARNINGS If accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternative means and then with this monitor to make sure it is working properly The cover should be removed only by qualified service personnel There are no user serviceable parts inside NOTES Do not spray or pour any liquid directly onto the
28. batteries External power supply and charger Wireless data transmission Wireless USB Adapter and PC software The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals NOTES This manual is for all possible configurations The monitor you use may not have all parameters as above mentioned United States Federal Law restricts this device to sale distribution and use by or on the order of a physician Explanation of Symbols LAN meist Conaasonpavin domns Chema mj pwoMam eue SSS wd Manufacturer O Electrostatic sensitive device Alarm general Prescriptive device operated by qualified personnel only vi Safety 1 Safety 1 1 Safety Information This chapter includes warnings cautions and basic safety information of NTID Vital Signs Monitor hereinafter referred to as monitor In addition the manual includes significant information relevant to the monitor display and operating instructions Important Read carefully before using All notes and precautions of important information are highlighted in the manual Warning Advice against certain actions or situations that could result in personal injury or death Caution Advice against actions or situations that could damage the equipment produce inaccurate data or invalidate a procedure Note Provides useful information that may b
29. d data will be saved if the monitor shuts down normally But if the batteries are taken out without powering off first during data recording it may cause data loss or disk damage e History trend data will be saved during shutdown process e History trend data will be saved if there is a low voltage alarm Then the monitor enters the low voltage status Replace batteries immediately No data will be stored in low voltage status even if the monitor is turned off normally 5 4 Event Table Screen Press the Down button to enter event table screen The event table displays alarm records of SpO PR or EtCO RR or all these parameters Refer to figure 5 5 00 00 ID 00 Date Time Type Des Figure 5 5 Event Table Operations 1 Press Right Left buttons to turn the pages after pressing OK when the cursor is on the selective frame Press OK again to exit NOTE The event table will only record alarms of recent 10 pages 5 5 Menu Options Press MENU key to access menu options as shown in figure 5 6 5 4 Displays and Functions Set Alarm Set Alarm a SpO and CO b SpO Only c CO Only Figure 5 6 Menu Screen Operations 1 Use Up and Down keys to scroll through different options Note You may scroll past the options shown to reach additional options 2 Press OK to select your option 3 Press MENU to exit 5 5 1 Setting Alarm N WARNINGS The monitor alarm function will be affected by environmenta
30. d strength in the location in which the NTID is used exceeds the applicable RF compliance level above the monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the NTID Over the frequency range 150 kHz to 80M Hz Field strengths should be less than 3 V m B 2 Appendix B Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EQUIPMENT or SYSTEM For EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Monitor The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the NTID can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NTID as recommended below according to the maximum output power of the communications equipment l Separation distance according to frequency of transmitter m Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHZ 800 MHz to 2 5 GHz transmitter 3 5 3 9 7 W d Br d Hr d Em For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transm
31. d symptoms Before using the monitor remove the plastic protective film that covers the screen This film is to protect the screen during transportation Keeping it on during monitoring can make it difficult to read measurement results 4 2 Powering Up 4 3 1 Buttons 1 2 E 3 A N a Ah 6 Figure 4 4 Buttons Number Description Function l Menu Enters or exits submenu Mute Turns off current alarm or enables all alarm sound EE Moves the cursor upwards or increases values mE EN Right Moves the cursor to the right or increases volume Moves the cursor downwards or decreases values 6 Confirms your selections Moves the cursor to the left or decreases volume 4 3 2 Powering Up 9 Installing batteries When the monitor is off press On Off button shortly to turn on the monitor if it 1s powered by battery The startup screen 1s shown as Figure 4 5 SYN EWTECH NT1D CO V1 00 Figure4 5 Starting Up Screen NOTES You will see the startup screen and then the monitor turns off automatically if the battery is low The monitor will have no response if the battery is too low Check the battery capacity The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms This monitor is a prescription device and is to be operated by qualified personnel only 4 3 Powering Up 9 Self Test The power indicator is
32. e neglected N WARNINGS Electric Shock Hazard The cover should be removed only by qualified service personnel There are no user serviceable parts inside The monitor is a prescription device and is to be operated by qualified healthcare personnel only When alarms happen the exact date and time on event table depends on the precision of date and time that the user has set in the monitor Explosion hazard The monitor is not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide Contacting the chemical substance from a cracked LCD display can cause poisoning Please handle with caution when the display is broken Please check the patient periodically to ensure that the monitor is working well and the correct positioning of SpO and CO sensors CO readings respiratory rate pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions The use of unspecified accessories transducers sensors and cables may result in increased emission and or decreased immunity of the equipment DO NOT silence the audible alarm if patient safety may be compromised Make sure that the speaker is not covered by any slipcover otherwise the alarm may not be heard Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditi
33. ensor measures CO by using the infrared absorption technique The principle is based on the fact that CO molecules absorb infrared IR light energy of specific wavelengths with the amount of energy absorbed being directly related to the CO concentration When an IR beam is passed through a gas sample containing CO the electronic signal from the photo detector which measures the remaining light energy is measured This signal is then compared to the energy of the IR source and adjusted to accurately reflect CO concentration in the sample The CO Sensor s response to a known concentration of CO is stored at the factory in the sensor s memory A reference channel accounts for optical changes in the sensor allowing the system to remain in calibration without user intervention Working theory of monitor signals from a patient are checked and magnified through various sensors and then transferred by extended cable to parameter module for data processing and then communicate with monitor s control board to show the result of measurement The result will be displayed on the screen in the form of a waveform and figures It can save up to 72 hours per parameter for up to 99 patients and it transfers data to a PC wirelessly N WARNINGS Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions probe application errors and certain patient conditions Specific information about ambient envi
34. f the monitor exposed please contact qualified service personnel Follow your local regulations regarding disposal of hospital waste Dispose or recycle of batteries and retired sensors and the monitor accessories according to standard operating procedures or local regulations for the disposal of contaminated medical waste This monitor cannot use disabled batteries Install new ones You can clean and disinfect the surface of the monitor and sensor Sensor is the only part that contacts to a patient so you should clean it after each use 10 5 1 Cleaning and Disinfecting the Monitor To clean the monitor s surface Dampen a soft cloth with a commercial non corrosive cleaner or 70 alcohol and wipe the top bottom and front panels lightly To disinfect the monitor Use a cloth dampened with 1096 aqueous solution of hypochlorite bleach 10 5 2 Cleaning and Disinfecting SpO Sensor You can use a soft cloth dampened with 70 alcohol to wipe the SpO sensor and then dry it completely with dry cloth The same for cleaning SpO sensor LED and receiver Clean and disinfect reusable SpO sensor Read SpO sensor directions carefully before cleaning Every type of SpO sensor has its own way to clean e If low level disinfection is required use a 1 10 bleach solution 10 5 3 Disinfecting Cable Clean and disinfect cables with 3 hydrogen peroxide or 70 isopropyl alcohol 10 5 4 Cleaning and Disinfecting CO
35. face of the sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution NOTES Do not sterilize by irradiation steam or ethylene oxide Do not use a blood pressure cuff or arterial blood pressure measurement device on the same limb to which the sensor 1s applied 6 5 Measurement Restrictions 6 5 1 Inaccurate SpO measurements may be caused by High frequency electrosurgical interference from a monitor or ambient electrical instruments connected to the system Excessive patient movement Inductive current generated from MRI may cause burn Outside light radiation 9 Incorrect sensor application or use Sensor temperature suitable temperature range should be28 C 41 C The same limb is used for sensor NTBP cuff artery tube or infusion tube Presence of COHb MetHb and dyestuff Weak signal Bad perfusion on sensor site Coma anemia low temperature and insufficient blood flow caused by drugs 6 3 Monitoring SpO NOTES The maximum time duration for one sensor site in use should be less than 4 hours The sensor surface temperature should not be higher than 41 C or it may cause burn During continuous monitoring sensor site should be cleaned at least every 12 hours Otherwise it may cause inaccurate measurements 6 5 2 Inaccurate measurements can also be ca
36. fety relevant labels for legibility Verify that the device functions properly as described in this operator s manual If the monitor is not functioning properly or fails any of the above tests do not attempt to repair the monitor Please return the monitor to the manufacturer or to your distributor for any required repairs 10 7 Guarantee The manufacture provides one year warranty for the monitor and CO sensor and three month quality warranty for SpO sensor The warranty does not cover the followings The monitor label of serial number is torn off or can not be recognized Monitor damage caused by misconnection with other devices Monitor damage caused by accidents Changes performed by users without prior written authorization of the manufacturer 10 5 Appendix A Appendix A Specifications A 1 Basic parameters SpO PR EtCO RR A 2 Mean Time Between Failures 71000 hours A 3 Normal Working Environment a Environment temperature range 0 40 C b Relative Humidity lt 95 95 c Atmospheric Pressure 700 1060 hPa d Power Voltage AC 100V 240V e Power Frequency 50 60 Hz f Battery type 4xAA size Ni MH rechargeable battery or alkaline battery forbid to charge alkaline battery A 4 Safety Requirements and Classifications a Electric shock type Type II equipment with internal power supply b Electric shock degree All application parts are BF type c Harmful liquid materia
37. ffects of the pulse in the body tissue Refer To Figure 6 1 LED AND INFRARED LED LIGHT SOURCES Oxi Pulse D LL a 96 Sp02 j 7 l 72 PULSE Eu ed d BARGRAPH LIII I I DETECTOR 6 1 Monitoring SpO Figure 6 1 SpO Theory of Operation The Pulse Oximeter processes these signals separating the time invariant parameters tissue thickness skin color light intensity and venous blood from the time variant parameters arterial volume and SpO to identify the pulse rate and calculateoxygen saturation Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood 6 3 Abnormal Conditions of SpO Measurement After turning on the monitor the following may occur due to the wrong sensor placement or other operations 1 Sensor off Finger The SpO sensor he 2 7 ady been inserted into the monitor but not attached to the finger the icon will blink and will display in SpO and PR area with high priority alarm sound every 10 seconds 2 Pulse search mode If the patient is connected with the sensor the monitor attempts to search pulse The icon 7 will blink At the same time will display in SpO and PR areas Normally the search lasts approximately 10 seconds If the pulse search fails the monitor generates high priority alarm 3 Sensor unplugged The icon E will display 4 Weak signal The icon w
38. ftware s version number and the serial number of this monitor 10 3 Factory Default Values Alarm parameter Default upper alarm limit Default lower alarm limit ECO mmHg 60 60 o 0 TS soe 19 9 B 9 ee 10 4 Product Return For return or repair of the monitor call the local representative for a RMA number and shipping instructions To pack the monitor for return disconnect all cables It is not necessary to return accessories Pack the monitor to be returned in its original shipping carton if available If not use a suitable carton with appropriate packing materials to protect the monitor during transportation 10 5 Maintenance and Cleaning N WARNINGS 10 2 Troubleshooting and Maintenance Covers should be removed only by qualified service personnel There are no user serviceable parts inside Turn the monitor off before cleaning Do not spray or pour any liquid directly onto the monitor or accessories Otherwise it will cause damage Do not immerse the monitor in liquid or use caustic or abrasive cleaners 0 f disinfection is required wipe the monitor surface with a soft cloth moistened with commercial nonabrasive cleaner Do not allow any liquid to enter any of the monitor s openings Do not touch or rub the display window with abrasive apparatus brush shaggy material or any other stuff that may cause damage to the display screen e If there are any internal parts o
39. han CISPR 11 Class A domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes Guidance and Manufacture s Declaration Electromagnetic Immunity for All EQUIPMENT and SYSTEMS Guidance and Manufacturer s Declaration Electromagnetic Immunity The NTID is intended for use in the electromagnetic environment specified below The user of NTID should assure that it is used in such an environment IEC 60601 test Compliance Electromagnetic level level environment guidance Electrostatic 6 kV 6 kV Floors should be wood concrete or discharge ESD contact contact ceramic tile If floors are covered with n 8 kV air synthetic material the relative humidity IEC 61000 4 2 8 kV air should be at least 30 Immunity test Power Power frequency magnetic fields should frequency be at levels characteristic of a typical 50Hz location in atypical commercial or magnetic field hospital environment IEC 61000 4 8 Appendix B Guidance and Manufacturer s Declaration Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and Manufacturer s Declaration Electromagnetic Immunity The NTID is intended for use in the electromagnetic environment specified below The user of NTID should assure that it is used in such an environment Immunity test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 test level 3 Vrms 150 kHz
40. iatric 3 When you choose the New button the system will auto generate a new ID The New button is not valid if there is no available ID 4 If you choose an ID that has never been used pressing OK button will change ID number and then exit If the ID you choose is in use it will remind you to substitute the former ID or cancel your operation 5 If you choose to substitute the ID the historical data of this ID will be cleared If you choose to cancel you will return to setting ID screen 5 5 5 Adjust Volume N WARNINGS Do not pause an audible alarm or decrease its volume if it could compromise patient safety Figure 5 11 Adjust Volume Note When the device is in operation you may change the volume of the audible pulse beep simply by pressing the Right increase or Left decrease buttons The steps below allow you to change the default setting that will be in place upon power up Operations 1 Use Up Down Right or Left buttons to move the cursor When the cursor is on OK or Cancel press OK to save or Cancel and exit You may also press MENU to exit 2 Adjust the volume with the Right and Left button Press the Up or Down key to move the cursor and then press OK to confirm Note Monitor will power up with the last confirmed alarm volume setting 5 8 Displays and Functions 5 5 6 Setting Date and Time Figure 5 12 Set Date and Time Note Date format is yyyy mm dd Operations 1 Use Right and
41. ill display 6 4 Applying SpO Sensor SpO sensors and a SpO saturation module are the components to monitor blood oxygen level of saturation SpO and or the pulse rate PR and other physiological parameters of patients The device is for use in but not limited to specialized medical facilities patient wards operation rooms first aid rooms emergency rooms and observation rooms NOTES The sensor is not suitable for continuous and long term SpO monitoring which may cause skin to become irritated reddening blistering or necrosis The SpO sensor has passed biological compatibility tests such as cytotoxic test intracutaneous stimulation and scratch test Procedures 1 Place an index finger over the sensor window with finger tip against the stop A The sensor should be oriented in such a way that the cable is positioned along the top of the hand B If an index finger cannot be positioned correctly or 1s not available other fingers can be used 6 2 Monitoring SpO A a c Figure 6 2 Placement of the Sensor 2 Insert the patient index finger into the sensor until the finger tip touches the end of the sensor Adjust the finger to be placed evenly on the middle base of the sensor C 3 Plug the sensor into the monitor and verify proper operation as described in the monitor operating manual 4 Inspect the monitoring site every 4 hours for skin integrity 5 Before each use clean the sur
42. inciples 1 oxyhemoglobin and deoxyhemoglobin which differ in their absorption of red and infrared light spectrophotometry and 2 changes in the volume of arterial blood in tissue during the pulse cycle plethysmography and hence light absorption by that blood 2 1 Introduction A pulse oximeter determines SpO by passing red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle Red and infrared low power light emitting diodes LEDs in the oximetry sensor serve as light sources a photodiode serves as the photodetector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its SpO measurements on the difference between maximum and minimum absorption measurements at systole and diastole The focus of light absorption by pulsatile arterial blood eliminates the effects of nonpulsatile absorbers such as tissue bone and venous blood CO theory of operation The CO Sensor is used for continuous measurement of CO and respiratory rate The s
43. ine battery There is some difference for Ni MH battery but will not affect operation Press On Off button with AC adapter in use the monitor will enter standby mode after the progress bar is full N WARNINGS n order to keep optimal performance of the equipment re start the monitor at least 30 seconds after the last shutdown or power off The history data can be saved only once when the battery icon is flashing After that the data won t be saved again even if the monitor is normally shut down 4 7 Powering Up 4 4 Device Storage Remove the batteries from the monitor before long term storage or if the device won t be used for more than 6 months This will protect the device from any damage due to possible battery leaking acid Keep the device in the original shipping carton and packing materials to protect it from any damage during storage 4 5 Environmental Protection To ensure minimum environmental pollution make sure to dispose the batteries appropriately in accordance with your local regulations ROHS 2002 95 EC and WEEE 2002 96 EC 4 6 Performance related Factors Inaccurate SpO measurements can be caused by Excessive patient movement Anaemia Venous pulsations 9 Intravascular dyes such as indocyaninegreen or methylene blue e Significant levels of dysfunctional hemoglobins Defibrillation The description of electromagnetic interference on oximetry reading is discussed in
44. itter Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However because of proliferation of radio frequency transmitting equipment and other sources of electrical noise in the health care and home environments for example cellular phones mobile two way radios electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device The monitor generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the site of use should be surveyed to determine the source of this disruption and actions taken to eliminate the source Turn the equipments in the vicinity of the monitor off and on to locate the source of the interference Reorient or
45. l light EMC noise etc The alarm sound and data flashing on the screen must be audible and visual to the operator a SpO and CO b SpO Only c CO Only Figure 5 7 Set Alarm limits Operations 1 Use Up Down Right and Left buttons to move the cursor When the cursor is on OK or Cancel press OK on device to save or cancel and exit You may also press MENU to exit 2 Press OK button to edit the fields you wish to change Use Up Right buttons to increase the value Use Left Down buttons to decrease the value Press OK to save and exit 3 When the cursor moves to CO option press OK button to switch to set alarm limit of EtCO and RR Only for SpO and CO module 5 5 Displays and Functions NOTE If the alarm limits are different from default values there is a dot displaying next to the limit values The dot will not disappear until the limits are resumed to default N WARNINGS No one other than trained personnel shall set up alarm limits Upper limits should not be lower than lower limits The alarm system will be invalid if you set alarm upper lower limits out of the range of alarm limits e If the patient needs special care improper alarm limits setting will cause the delay or invalidation of alarm signals Make sure that the default alarm settings are appropriate for the specific patient being monitored 5 5 2 Setting SpO In the setting menu you can choose Set SpO
46. l proof degree Liquid proof IPX1 d Disinfection Follow manufacturer s recommended methods e Safety on flammable gas Not suitable to use where flammable gas is present f The monitor has applicable parts g Power supply Internal power supply 4 4 6 0V 4xAA size batteries II type power adapter Input AC100 240V 50 60Hz Output DC 9V operation power and 6 0V Recharging power h The monitor has signal input and output parts i e buttons LCD wireless interface i When using external power supply the monitor is a continuous working system When using batteries working time is about 2 hours for SpO and CO A 5 Trend Data Transfer 1 Support real time wireless transmission Wireless via USB Adapters for PC 2 RF frequency 2 440GHz 3 Modulate mode GFSK 4 Effective transfer distance lt 1m 5 Transfer speed lt 40kbps 6 Transfer time lt 40secs per ID 7 Power consumption Rx or Tx Peak x13nA A 6 SpO m Measurement range 0 100 mMeasurement accuracy 70 100 2 0 69 not required A Appendix A A 7 PR m Measurement range 30 250 bpm m Measurement accuracy 1 bpm or 296 whichever is greater A 8 EtCO m Measurement range 0 150mmHeg mResolution 0 lmmHg 0 69mmHg 0 25mmHg 70 150mmHg m Measurement accuracy 2 mmHg 0 40mmHg 5 41 70mmHg 8 71 100mmHg 10 101 150mmHg A 9 RR m Measurement range 0 150 bpm m Measurement accuracy 1 bpm A 10 A
47. larms m Alarm Priorities Priority Low voltage Loss of pulse Sensor Technical alarm off Cable off CO sampling line off No breath bhvstoldeicalalsm Parameter s value exceeds limits The priority can be y 8 adjusted to high or medium Audible alarm Dee Dee Dee Dee Dee Dee Dee Dee Every 10s Every 25s Figures Displays with related icon Numeric blinking 8 indication Refers to chapter 5 1 Frequency 0 625Hz Blinking Red Blinking Yellow Frequency 2Hz Frequency 0 5Hz Record the event such as the date time parameters etc Indicator light m Alarm Types e Physiological alarm Patient s physiological parameters exceed limits Technical alarm System failure to lead wrong results 1 e sensor off General alarm No harm to patient health but needs attention i e Battery low voltage A 11 Factory Default Values of Alarm Parameter A 2 Appendix A Alarm Parameter Default Upper Alarm Limit Default Lower Alarm Limit ECO mmHg 60 o eR 31571313 a LANE 4 1 3 12 A 12 Limits Setting and Tolerance of Upper Lower Limits Alarm Parameter Range of Upper Limit Range of Lower Limit 21i 100 PR 35 bpm 250 bpm 30 bpm 245bpm RR i iWpm O iBbm A 13 Continuous Working Time Power supply Internal 4xAA alkaline or Ni MH batteries or external power source The monitor switches to external power source immediately when connected to AC powe
48. logy SpO Percent oxygen saturation PR Pulse beats per minute bpm Initiating CO monitoring 1 Connect the CO sensor to the monitor and adapter correctly 2 Press MENU to enter the setup option and turn on CO switch will appear in EtCO and RR display area 1f CO sensor has already been connected without CO input 4 4 Powering Up 3 If there is CO input patient end tidal carbon dioxide value and respiration rate will be displayed in the EtCO2 and RR display area Terminology EtCO end tidal carbon dioxide value and has three Units kPa mmHg default RR respiration rate per minute bpm 4 3 4 Information Bar The information bar displays as shown in figure 4 7 from left to right time alarm and mute status full disc patient ID and type and battery capacity Figure 4 7 Information bar General alarm is on but single parameter alarm may be turned off Alarm General alarm 1s off No alarms other than low battery alarm is available DEBE Alam forallpanmstesison 00 Baia Recording B Serine history data ofeurentusee Memory Fal B Memory fil Saving daia soppe 4 3 5 Status Bar Sensor unplugged E E Sensor is not plugged in the socket Sensor off finger EN Sensor is not attached to finger Search pulse a Pulse searching in progress Weak signal E E It will be displayed if the patient signal is low 4 3 6 Pulse Tone Volume Press Left Right ar
49. lood poisoning or acute fever If the concentration of CO is low it is commonly due to a weak output ability of the heart or the heartbeat stopped or insufficient blood flow with less oxygen Monitoring CO is used to warn the doctor of the abnormal breathing and metabolizing during anaesthesia The measurement value of CO is represented by a pressure level with the unit mmHg or 95 Generally the maximum acceptable value is 38mmHg 5 when air pressure is 760mmHg The concentration of CO varies rapidly from 0 to 5 To detect the concentration of CO accurately the monitor needs to be very sensitive The monitor is used to measure EtCO and respiration rate of adult and pediatric patients 7 3 Applying the CO Sensor The CO Sensor is used to continuously monitor carbon dioxide and report ETCO2 inspired CO and respiratory rate of intubated and non intubated adult and pediatric patients The CO Sensor is intended for use in but not limited to intensive care units anesthesia medical surgical units LTAC units emergency rooms sleep labs intra hospital and inter hospital transportation For use in monitoring patients in respiratory distress respiratory arrest asthma COPD or other disorders where the patient s ETCO and capnogram will be helpful in the treatment of the patient For use in monitoring patients pre and post intubation 7 1 Monitoring CO 0 To assist the patient in the management
50. monitor accessories or consumables Otherwise it may cause damage to the monitor If you discover a problem while using the monitor do not continue to use or try to fix it Contact qualified service personnel or representative The monitor service manual which is for use by qualified service personnel provides additional troubleshooting information 10 1 Errors and Solutions 1 Monitor does not turn on after pressing the power switch Check power cable connection Replace or recharge the battery pack or connect to AC power Be sure the battery pack is in the monitor and inserted properly 2 One or more displayed parameters or indicator icons do not light up during self test Do not use the monitor and contact technical service department 3 Indicator icon of searching pulse is blinking more than 10 seconds Check if the sensor is suitable or connected correctly following sensor directions for use Check the sensor and its cable connection Try this sensor on another person Try another sensor or another extension cable Blood insufficient supply may cause failure of detecting pulse Check the patient or try the monitor on yourself Replace the sensor or try another sensor 0 Interference from patient movement may affect pulse searching Keep the patient quiet Check the sensor placement Replace the sensor if necessary or move the sensor to a new site The probe may be placed too tight Ambient light may
51. nician for help 3 4 Unpacking and Installing Figure 3 5 Installing Wireless USB Adapter Installing steps 1 Install driver software on PC 2 Plug the wireless USB Adapter into PC The USB Adapter receives data from monitor wirelessly as shown in Figure 3 5 Place the monitor within 2 meters to PC and the monitor will send the data to USB Adapter wirelessly Press MENU button to select Sending Data option Choose Connect button to start software After a successful connection in the side column the software will display patient history data that have been stored in the monitor 9 QN CA 4 NOTES 9 n order to ensure the quality of the transmission signal keep the monitor as close to the USB wireless adapter as possible Make sure there is no barrier between them This monitor complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference 2 This device must accept any interference received including interference that may cause undesired operation The monitor should be placed at least 20cm away from all persons when used to transmit data 3 6 Sensor Placement N WARNINGS Read the sensor instructions before use including warnings cautions and instructions Do not use a damaged sensor Do not immerse or wet the sensor in liquid Do not use a sensor with exposed electronic comp
52. ompensation 3 CQ warm up 4 NO breath detected 5 During zeroing process Completing above process CO waveform will turn back to original baseline NOTE For optimal performance connect CO Sensor to an adapter and wait for 20 seconds before the Adapter Zeroing procedure Unplug adaptor this monitor main window will hint checking CO adaptor and occur high level alarm N WARNINGS CO readings and respiration rate can be affected by certain ambient environmental conditions sensor application errors and patient conditions Check whether the CO adapter is damaged or not Do not use damaged CO adapters If CO waveform Capnograph appears abnormal Inspect the CO airway adapters and replace if necessary Replace CO airway adapters if excessive discharge is observed Monitor CO waveform Capnograph for elevated baseline Elevated baseline can be caused by sensor or patient 7 2 Data Output Data Output 8 1 Driver Installation and Copy of Data Analysis Software Install the driver F32x Express USB Driver and copy the folder History Data Viewer from the enclosed CD to PC before data transmission from monitor to PC 8 1 1 USB Driver Installation F32x Express USB Driver is a USB adapter driver Following below steps to install 1 2 Insert the enclosed CD into your PC Plug the USB adapter into USB port on PC and you will see an automatic popup window
53. onents NOTES Use only recommended sensors and cables for SpO and CO measurements Other 3 5 Unpacking and Installing sensors may cause inaccuracy Do not lift the monitor by the sensor cable or it may cause the monitor to fall on the patient Use the appointed SpO and CO sensors to ensure the monitor working conditions Do not connect anything other than a SpO sensor to the SpO sensor socket for example do not attempt to connect a PC to the monitor through SpO sensor socket Do not connect anything other than a CO sensor to the CO sensor socket Ba The connection of SpO sensor La La Bd E L3 The connection of CO sensor B 4 Figure 3 6 Installing sensors 9 Installing the SpO sensor 1 Select an appropriate sensor for the patient 2 Refer to Figure 3 6 Connect the sensor to the monitor socket 3 Attach the finger probe with the light to the patient Be sure to fully insert the patient s finger into the probe 4 Apply the sensor following the instructions supplied with the sensor 9e Installing CO sensor 1 Insert the CO Sensor into the monitor socket To remove the sensor grasp the connector and pull back 2 Figure 3 7 shows how to connect mainstream or Sidestream CO sensor SpO sensor t SpO sensor g Padi Mainstream CO sensor ER f gt Bd Qs p P i va SY gt Jy i Figure 3 7 Installing
54. ons Before using the monitor verify that the alarm limits are appropriate for the patient to be monitored To ensure accurate performance and prevent device failure do not expose the monitor to extreme moisture such as rain The SpO sensor must be moved to a new site at least every 4 hours Due to the fact that Individual skin conditions may affect the ability to tolerate sensor placement it may be necessary to change the sensor site more frequently for some patients If the skin integrity changes move the sensor to another site 1 1 Safety DO NOT use the monitor during magnetic resonance imaging MRI scanning Inducted current could cause burns The monitor may affect the MRI image and the MRI unit may affect the accuracy of monitor s measurements The monitor has no defibrillation synchronization so it cannot be connected to defibrillators Follow precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment To ensure patient electrical isolation connect only to other equipment with circuits that are electrically isolated If the accuracy of any measurement appears questionable check the patient s vital signs by alternate means and then make sure the monitor is functioning correctly This monitor can save current patient s data only when it is shut down normally or in low voltage therefore 1 When using internal power supply shut
55. or in any position that might cause it to fall on the patient Carefully route patient cabling SpO sensor and CO sensor to reduce the possibility of patient entanglement or strangulation Be sure to follow local regulations and recycling instructions regarding disposal or recycling of batteries This monitor s electrical 1solation part 1s centralized in AC adapter When using external power supply or charging the batteries please use only the medical grade AC adapter provided by the manufacturer If the integrity of the main supply connection appears questionable operate the monitor from its internal battery pack Reuse disassemble cleaning disinfecting or sterilizing the single patient use CO airway adapters may compromise functionality and system performance leading to user or patient hazards Performance is not guaranteed if a disposable single patient use sensor is reused e If the SpO and CO Sensor fails to respond as described in this manual DO NOT use it until it s approved for use by qualified personnel 1 2 Safety The CO Sensor is not patient isolated Use of the sensor does not require direct patient contact If isolation is desired or required it is the responsibility of the Host system to provide necessary isolation The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Do not reuse disposable accessories
56. oring time exceeds the limits e Shutting down the monitor will cause the real time trend data to be cleared 5 3 2 Trend Table Screen Press Down button to enter trend table screen See Figure 5 4 00 00 00 00 ID 00 00 00 ID 00 Time Date Time Date Time 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 00 00 00 00 01 00 00 00 00 00 01 00 00 00 00 a SpO and CO b SpO Only c CO Only Figure 5 4 Trend Table Screen Operations 1 Press Right Left buttons to turn the pages after pressing OK when the cursor is on 5 3 Displays and Functions the page up down frame Press OK again to exit 5 3 3 History Trend History trend will be stored in three ways as below No data will be stored in disk if patient ID is 00 The latest 72 hour data will be stored if patient ID is from 01 to 99 If the disk is full the full disk icon will display in the status bar and no more data will be recorded The history data is saved every 10 seconds The recorded data includes the values of SpO PR CO and RR NOTES History tren
57. ound the software will remind you to choose the patient ID whose data you want to upload to PC You can upload patient data to PC or delete patient data 4 During the process of data transmission you can press Stop button to stop and exit 5 5 9 Module Options Figure 5 15 Set Module There are three modules SpO and CO SpO Only and CO Only You can choose any of these to run after entering Set Module submenu 5 5 10 Resume Settings Enter Reset Setting submenu to resume all settings you have changed as shown in Figure 5 16 Figure 5 16 Resume Settings 5 5 11System Information System information includes the information of hardware and software see Figure 5 17 5 10 Displays and Functions Figure 5 17 System Information 5 6 Audible and Visual Indications The following audible indications do not change with symbols key board or visual indication No Description Visual indication During self test the indicator light will flash red yellow and green Pulse Sound The red light will blink and the icon Dee dee dee dee dee Sensor will be displayed Dee dee dee dee dee Unplugged Every 10s The red light will blink and the icon Dee dee dee dee dee Sensor Off will be displayed Dee dee dee dee dee Every 10s Startup Dee dee dee dee dee Poor Signal The icon EL will be displayed Dee dee dee dee dee Every 10s The red light and the icon BH will Dee dee dee
58. r DO NOT charge alkaline batteries Internal power continuous working time SpO amp CO about 2 hours A 14 Trend Data Storage m Memory of trend data Up to 99 patient IDs 72h trend data per ID m Stored parameters of trend data SpO PR EtCO RR Time etc A 15 Dimensions and Weight Dimensions Net Weight It G Weight k 125x73x23 0 137 0 23 with batteries Adapter A 16 Packing Transportation and Storage m Packing Place the monitor in a plastic bag and place it in a corrugated carton filled with foam or other fillers Seal the carton m Transportation The monitor can be transported by airplane train or automobile Prevent fierce collision during transportation Do not keep it with perishables The transportation environment should be A 3 Appendix A a Environment temperature range 20 C 70 C b Relative humidity range lt 95 c Air pressure range 500hPa 1060hPa m Storage The monitor should be stored indoors with a temperature range 10 C 407C relative humidity lt 80 no corrosive gas and with good ventilation A 17 Explanations of Interface Wireless Connects to PC via wireless USB Adapter 2 440GHz PC end ISM band Wireless Built in RF to communicate with wireless USB Adapter handheld end with data rate up to 40kbps 2 440GHz ISM band DB9 SpO Connector Standard DB9 F Connector DB9 CO Connector A 18 Compliance Standards Applied Standards of NT1D EN6
59. rdware Wizard Found Mew Hardware Wizard Finish to the Found Sew Hardware wizard TIS EISE Fats Expres LH Discs Click Finish to complete the installation of F32x Express USB Driver Once the driver is installed on PC there is no need to install for the second time 8 1 2 Copy the Folder History Data Viewer The software in this folder has functions of data output data analysis and report printing Copy the folder History Data Viewer from CD to PC and double click the icon to open the main screen of the History Data Viewer software Click OK to start 8 2 Data Transmission and Deletion NOTES In the process of data transmission or deletion do not close History Data View software or remove the USB adapter otherwise the process will fail After data transmission or deletion remove the USB adapter first then close the History Data View software 1 Place the monitor within 2 meters around the PC and turn it on 8 2 Data Output 2 Press the MENU and select Data Output The monitor will stay in below dialogue as shown in the following figure Waiting for PC 3 Open history data viewer software and click 1 at the top left corner to connect the monitor to PC wirelessly After successful connection patient history data which have been stored in the monitor will be displayed on the left side column of the monitoring software Select one p
60. relocate other interfering devices Set up increase the isolation measures between the interfering equipment and this monitor B 3
61. ronmental conditions probe applications and patient conditions is contained throughout this manual 2 4 Terminology Pleth Blood dimension RR Respiration rate End tidal carbon dioxide value Unpacking and Installing 3 Unpacking and Installing 3 1 Unpacking Open the package according to the marks on the box Remove the monitor and accessories carefully Check the accessories according to the packing list Check the monitor and accessories for any damage If any problem is detected contact your local representative immediately Friendly Reminder The packing material should be saved for future transportation and storage N WARNINGS Keep the packaging materials from children Follow local regulations or hospital policies to dispose packaging materials The equipment may be infected by microorganism during transportation Check the packaging before using the monitor Do not use it if damaged 1s present 3 2 Installing Batteries Figure 3 1 Installing Batteries 1 Slide downward to open the battery compartment The battery cover visible battery warning label see Figure 3 2 Figure 3 2 Battery Warning Label 2 Install the four batteries into the monitor oriented as shown in figure 3 1 Put the battery cover back 3 Unpacking and Installing This monitor can use both Ni MH batteries as well as alkaline batteries When using Ni MH Batteries you can use an external AC adapter or
62. row buttons to adjust pulse volume any time except in trend graph screen 4 5 Powering Up 4 3 7 Battery Capacity Indicator and Recharge N WARNINGS Be sure to follow local regulations and recycling instructions regarding disposal or recycling of batteries Do not recharge alkaline batteries Low battery alarm is high priority alarm which cannot be disabled NOTES The remaining battery time is estimated according to battery types This indicator icon will display when the battery capacity is less than 15 minutes Remaining battery time may differ from different types of batteries Check the batteries periodically for corrosion Remove all batteries if you don t intend to use the monitor for more than three months Battery Capacity Indicator The battery icon in the information bar indicates the remaining battery capacity in a working mode It will flash and the low battery alarm will be on if the remaining battery time is less than 15 minutes See Figure 4 8 Figure 4 8 Low Battery Icon If the battery is too low the monitor will pop up a warning message and the monitor will turn off itself as shown in Figure 4 9 Tarning Lor Battery Yoltage Figure 4 9 Low Battery Warning Message Recharge If the monitor 1s connected to a power cable or the charging base when the monitor is off Press the On button it will start up automatically and display charging screen with the battery icon fla
63. s current EtCO value Or displays without EtCO measurement 4 RR Value Displays current RR value Or displays without RR measurement 5 SpO waveform Displays SpO waveform Or displays a straight line without SpO measurement EtCO waveform Displays EtCO waveform Or displays a straight line without EtCO measurement Alarm Limits Upper and lower limits of current parameter Alarm Switch The alarm of current parameter is off if the icon is displayed Note Press the Up Down key to switch among the main monitoring screen the big chart screen the trend graph screen and the trend table and event table 5 2 Big Chart Screen Pulse graph Displays the strength of pulse Press the Down button to enter real time big chart screen see Figure 5 2 5 1 Displays and Functions a SpO and CO Module b SpO Only c CO Only Figure 5 2 Big Chart Mode In the monitoring screen press MUTE button to disable current alarm or enable all alarms 5 3 Real time Trend Screen 5 3 1 Trend Graph Screen Press the Down button to enter real time trend graph screen displaying parameters trend graph of SpO 2 PR EtCO and RR It records 1 event every 10 seconds 30 minutes per page and a total 6 pages To shut down the monitor modify ID change time and interval will clear any current data and the new real time trend graph will display See Figure 5 3 Press Right Left buttons to select single parameter trend
64. shing The battery icon will appear full after the charging is completed Press on off button to enter real time monitoring screen If you unplug the power cable or disconnect the charging base when the monitor is off the monitor turns off automatically See Figure 4 10 Figure 4 10 Charging Screen 4 6 Powering Up If the monitor is connected to a power cable or the charging base when it is working the bars inside the battery icon will flash Four full bars mean the battery is fully charged You may continue to use the monitor after you disconnect the power cable or the charging base 4 3 8 Powering off 1 Normal shutdown Press and hold On Off button until the progress bar is full to turn off the monitor The message below displays shutdown in progress Figure 4 11 Figure 4 11 Normal Shutdown 2 Shutdown in Low Battery The monitor turns itself off automatically when batteries are depleted The system enters into the state of low voltage status at least 15 minutes before shutdown The battery icon will flash and history data of current ID will be saved Change or recharge batteries after normal shutdown NOTE No more data will be saved when the battery icon is flashing The monitor pops up a message during low battery shutdown see Figure 4 9 and the shutdown progress can not be terminated NOTES You can not terminate shutdown progress in low battery status The low battery capacity is estimated by alkal
65. t Risk management und edical devices Application of risk management requirement o medical devices dii dE symbols for use in the label of medical devices by the manufacturer medical devices DENS deos investigation of medical devices for human 14155 1 2009 subjects General requirements nuo 4 Clinical investigation of medical devices for human Clinical requirement 14155 2 2009 REM eee Clinical investigation plans Guidance of clinical Evaluation of clinical data a guide for manufacturers evaluation Med dev and notified bodies 2 7 1V3 A 5 Appendix B Appendix B EMC Electro Magnetic Compatibility Caution The monitor complies with the limits for medical devices to EN60601 1 2 2007 Medical Device Directive 93 42 EEC and this monitor has been tested for CISPR 11 class A Guidance amp Manufacturer s Declaration Electromagnetic Emissions for All EQUIPMENT and SYSTEMS Guidance and Manufacturer s Declaration Electromagnetic Emission The NTID is intended for use in the electromagnetic environment specified below The user of NTID should assure that it is used in such an environment Emission Compliance Electromagnetic environment guidance test RF The NTID uses RF energy only for its internal function emissions Group 1 Therefore its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment RF emission The NTID is suitable for use in all establishments other t
66. terminal clears the positive spring Press the battery downward into place To remove the batteries reverse the installation process remove the positive end of each battery first To avoid corrosion of the contacts remove batteries from the battery compartment if you do not intend to use the monitor for an extended period of time 3 3 Installing Power Adapter N WARNINGS Use the appointed power adapter or charging base to charge Ni MH Batteries DO NOT use any other power adapter or charging base Connect the Power Adapter to the Monitor Power Adapter Monitor Figure 3 3 Installing Power Adapter 1 Plug the AC adapter into the charging connector on the bottom of the monitor 2 Connect the AC adapter to the monitor power socket 3 If the monitor is off Press the On button it will start up and display the charging screen Press the On button again to start monitoring 4 If the monitor is working the battery icon will flash 3 3 Unpacking and Installing 3 4 Installing Base AC 100 240V 0 80Hz e E Connect the Power Adapter to the Base M Power Adapter Base Figure 3 4 Installing Base Plug the AC adapter into the connector at the rear of the base Put the monitor into the base in the right direction to ensure the contact of the metal points Connect the AC adapter to the electrical outlet If the monitor 1s off Press the On button it will start up and display the charging screen
67. the Troubleshooting and Maintenance of this manual Inaccurate CO measurements can be caused by e Filter line entanglement or strangulation Reuse disassemble cleaning disinfecting or sterilizing the single patient use CO airway adapters Air flow adapter is damaged CO sensor is damaged CO sensor is wet or has exterior condensation Nitrous oxide elevated levels of oxygen helium and halogenated hydrocarbons can influence the CO measurement Air flow adapter windows are dirty CO Sensor windows are dirty 0e Patient s discharges CO sensor has not been zeroed for airway adapter Environment configuration has not been set up for the CO sensor Environmental conditions and sensor application errors may affect SpO and CO measurements and readings Refer Sensor Application of the manual as well as Sensor Application Guidance 4 8 Displays and Functions 5 Displays and Functions 5 1 Main Monitoring Screen After turning on the monitor you will enter the main monitoring screen Its basic function is to display parameters of the patient s vital signals See Figure 5 1 a Double Waveform Screen b SpO Only Module c CO Only Module Figure 5 1 Main Monitoring Screen I SpO Value Displays current SpO value Or displays without SpO measurement 2 PR Value Displays current PR value Or displays without PR measurement 3 EtCO Value Display
68. the charging base But when using alkaline batteries you CANNOT use any external AC adapter or the charging base to recharging N WARNINGS Never operate the device without the battery cover in place Use 4 AA size Ni MH Batteries or alkaline batteries DO NOT use any other batteries without recommendation When using alkaline batteries DO NOT use any external AC adapter or the charging base for recharging DO NOT mix Ni MH Batteries and alkaline batteries Do not rechange alkaline non rechargeable batteries Do not mix use of alkaline and 2400mah Ni MH batteries Unplug power to docking prior to using alkaline batteries Rechargeable Ni MH batteries must be 2400mah gt Use of Ni MH Batteries Do not immerse the battery pack in liquid Only recharge the battery pack in the monitor provided by your local representative to avoid possible overheating burning or rupture of the battery pack gt Storage of Ni MH Batteries e Short term storage within one month The battery pack has an automatic discharge feature Check the battery capacity periodically Long term storage 6 months or more The battery pack must be stored in a cool dry area The battery capacity decreases over time To restore the battery pack to full power recharge and discharge it three times before use Long term storage without charging may degrade the battery capacity gt Disposal of Ni MH Batteries
69. tinuous measurement of CO and respiratory rate The sensor measures CO by using the infrared absorption technique The principle is CO molecules absorb infrared IR light energy of specific wavelengths with the amount of energy absorbed being directly related to the CO concentration When an IR beam is passed through a gas sample containing CO the electronic signal from the photo detector which measures the remaining light energy is measured This signal is then compared to the energy of the IR source and adjusted to accurately reflect CO concentration in the sample The CO Sensor s response to a known concentration of CO is stored at the factory in the sensor s memory A reference channel accounts for optical changes in the sensor allowing the system to remain in calibration without user intervention 7 2 Theory of Measurement CO monitoring is to monitor the respiration of a patient by detecting the concentration of CO generated during respiration The maximum concentration of CO at the end of exhalation is called End Tide CO EtCO The minimum concentration of CO at the end of inspiration is called Inspiration CO F1iCO CO is generated by cells in the body during metabolizing and is breathed out via breathing system The concentration of CO breathed out from the lung reflects directly the situation of metabolizing and breathing system If the concentration of CO 1s high it means that metabolism is over active such as b
70. to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance level Portable and mobile RF communications equipment should be used no closer to any part of the NT1D including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 Electromagnetic E WP environment as guidance VF 80 MHz to 800 MHz 7 mi ve 800 MHz to 2 5 GHz Where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE I At 80 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters An electromagnetic site survey should be considered If the measured fiel
71. used by 9 Incorrect application of the sensor 0 Patient s finger is too big or poor blood circulation Failure to cover the sensor site with opaque material in high or ambient light conditions prolonged and or excessive patient movement 9 Intravascular dyes such as indocyaninegreen or methylene blue Interavascular dyes or externally applied coloring such as nail polish or pigmented cream Venous pulsations e Significant levels of dysfunctional hemoglobins e Insufficient blood supply 6 5 3 Loss of pulse signal can occur with any of the following The sensor is too tight Defibrillation A blood pressure cuff is inflated on the same extremity as the one to which an SpO sensor is attached 0 There is arterial occlusion next to the sensor 0 Peripheral insufficient blood supply Loss of pulse or heart arrest Select an appropriate sensor apply it as directed and read all warnings and cautions presented in the directions for use of the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient High ambient light sources such as surgical lamps especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of a SpO sensor To prevent interference from ambient light ensure th

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